Clinical trial · Interventional
Perillyl Alcohol in Treating Patients With Refractory Cancer
A PHASE I STUDY OF PERILLYL ALCOHOL IN PATIENTS WITH REFRACTORY MALIGNANCIES (NSC #641066)
NCT00002862CI-TRIAL-00009424completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of perillyl alcohol in treating patients with refractory cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perillyl alcohol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Groups of 3-6 patients receive escalating doses of oral perillyl alcohol three times per day until the maximum tolerated dose or recommended phase II dose is determined. Treatment at the assigned dose continues until disease progression or unacceptable toxicity intervenes. Patients with stable disease after 8 weeks of treatment are removed from study.
- interventionNames
- Drug: perillyl alcohol
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid malignancy or lymphoma for which no effective therapy exists * Measurable or evaluable disease * No CNS metastasis unless stable for at least 4 weeks following surgery and/or radiotherapy and no requirement for anticonvulsants PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-2 * Life expectancy: At least 3 months * ANC at least 1,500 * Platelets at least 100,000 * Bilirubin no greater than 2.0 mg/dL * AST less than 2.5 times normal * Creatinine clearance at least 50 mL/min * No concurrent cholesterol-lowering agents * No active infection (including HIV) * No concomitant medical condition that precludes study compliance * No pregnant or nursing women * Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: * At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) * At least 4 weeks since wide-field radiotherapy * Fully recovered from prior surgery
References
Publications (0)
Data not yet available
No reference posted for this study.